SaMD Design Quality & Compliance Engineer

Heidi Health Corp.; Greater London; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Private medical and dental cover (Bupa

24/7 mental health

Wellbeing support through Sonder

Healthy Heidi's wellness stipend

Home office budget

Learning and development budget

Parental leave benefits

Hybrid working 3 days in office

Job summary

Heidi Health Corp. is seeking a Design Quality & Compliance Engineer to embed regulatory best practices within an agile software org. Reporting to Legal & Regulatory Affairs and collaborating with Engineering, you’ll ensure medical software meets global device standards.

You will drive design control per IEC 62304, ISO 14971 and ISO 13485, translating complex rules into practical processes for engineers and product teams, and supporting audits and regulatory submissions.

Qualifications

• SaMD experience in regulated healthtech, preferably startup/scale-up.
• Strong working knowledge of IEC 62304, ISO 14971, ISO 27001 and practical application.
• Solid understanding of cloud security, access control, network security, and secure SDLC.
• Proactive, detail‑oriented, and capable of delivering high‑quality work in a fast‑paced environment.
• Excellent collaboration and communication with engineers, product, auditors and customers.

Responsibilities

• Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with IEC 62304, ISO 14971, and ISO 13485.
• Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined, documented, and traceable.
• Support the creation and maintenance of technical documentation, including requirements specifications, risk management files, verification reports, and change records.
• Support external ISO 13485 audits, focusing on Design and Development aspects.
• Champion compliance in software development by translating IEC/ISO standards into actionable processes for engineering teams.

Skills

SaMD Experience

Standards knowledge

Technical security

Proactive & detail‑oriented

Collaboration & communication

Education

Bachelor’s degree or higher in a relevant field

Job description

Heidi Health Corp. is seeking a Design Quality & Compliance Engineer to embed regulatory best practices within an agile software org. Reporting to Legal & Regulatory Affairs and collaborating with Engineering, you’ll ensure medical software meets global device standards.

You will drive design control per IEC 62304, ISO 14971 and ISO 13485, translating complex rules into practical processes for engineers and product teams, and supporting audits and regulatory submissions.